{"title"=>"Qualichem in vivo: A tool for assessing the quality of in vivo studies and its application for bisphenol a", "type"=>"journal", "authors"=>[{"first_name"=>"Laura", "last_name"=>"Maxim", "scopus_author_id"=>"55673974700"}, {"first_name"=>"Jeroen P.", "last_name"=>"Van Der Sluijs", "scopus_author_id"=>"7003576366"}], "year"=>2014, "source"=>"PLoS ONE", "identifiers"=>{"pmid"=>"24489958", "sgr"=>"84897408686", "doi"=>"10.1371/journal.pone.0087738", "scopus"=>"2-s2.0-84897408686", "pui"=>"373070272", "issn"=>"19326203"}, "id"=>"c5f696fc-3d32-3a28-a719-68257ac25c55", "abstract"=>"In regulatory toxicology, quality assessment of in vivo studies is a critical step for assessing chemical risks. It is crucial for preserving public health studies that are considered suitable for regulating chemicals are robust. Current procedures for conducting quality assessments in safety agencies are not structured, clear or consistent. This leaves room for criticism about lack of transparency, subjective influence and the potential for insufficient protection provided by resulting safety standards. We propose a tool called \"Qualichem in vivo\" that is designed to systematically and transparently assess the quality of in vivo studies used in chemical health risk assessment. We demonstrate its use here with 12 experts, using two controversial studies on Bisphenol A (BPA) that played an important role in BPA regulation in Europe. The results obtained with Qualichem contradict the quality assessments conducted by expert committees in safety agencies for both of these studies. Furthermore, they show that reliance on standardized guidelines to ensure scientific quality is only partially justified. Qualichem allows experts with different disciplinary backgrounds and professional experiences to express their individual and sometimes divergent views-an improvement over the current way of dealing with minority opinions. It provides a transparent framework for expressing an aggregated, multi-expert level of confidence in a study, and allows a simple graphical representation of how well the study integrates the best available scientific knowledge. Qualichem can be used to compare assessments of the same study by different health agencies, increasing transparency and trust in the work of expert committees. In addition, it may be used in systematic evaluation of in vivo studies submitted by industry in the dossiers that are required for compliance with the REACH Regulation. Qualichem provides a balanced, common framework for assessing the quality of studies that may or may not be following standardized guidelines.", "link"=>"http://www.mendeley.com/research/qualichem-vivo-tool-assessing-quality-vivo-studies-application-bisphenol", "reader_count"=>20, "reader_count_by_academic_status"=>{"Student > Doctoral Student"=>2, "Researcher"=>5, "Student > Ph. D. Student"=>2, "Student > Postgraduate"=>1, "Student > Master"=>4, "Student > Bachelor"=>4, "Professor"=>2}, "reader_count_by_user_role"=>{"Student > Doctoral Student"=>2, "Researcher"=>5, "Student > Ph. D. Student"=>2, "Student > Postgraduate"=>1, "Student > Master"=>4, "Student > Bachelor"=>4, "Professor"=>2}, "reader_count_by_subject_area"=>{"Unspecified"=>2, "Environmental Science"=>7, "Nursing and Health Professions"=>1, "Medicine and Dentistry"=>2, "Agricultural and Biological Sciences"=>2, "Pharmacology, Toxicology and Pharmaceutical Science"=>1, "Business, Management and Accounting"=>1, "Social Sciences"=>2, "Computer Science"=>1, "Economics, Econometrics and Finance"=>1}, "reader_count_by_subdiscipline"=>{"Medicine and Dentistry"=>{"Medicine and Dentistry"=>2}, "Social Sciences"=>{"Social Sciences"=>2}, "Economics, Econometrics and Finance"=>{"Economics, Econometrics and Finance"=>1}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>2}, "Computer Science"=>{"Computer Science"=>1}, "Nursing and Health Professions"=>{"Nursing and Health Professions"=>1}, "Business, Management and Accounting"=>{"Business, Management and Accounting"=>1}, "Unspecified"=>{"Unspecified"=>2}, "Environmental Science"=>{"Environmental Science"=>7}, "Pharmacology, Toxicology and Pharmaceutical Science"=>{"Pharmacology, Toxicology and Pharmaceutical Science"=>1}}, "reader_count_by_country"=>{"United States"=>1, "Norway"=>1, "Brazil"=>1, "United Kingdom"=>1}, "group_count"=>2}

{"files"=>["https://ndownloader.figshare.com/files/1365879"], "description"=>"<p>For the study of Tyl et al. (2002), of the 45 criteria, the figure represents only the 30 controversial criteria for the two respondents who included “endocrinology” or “endocrine toxicology” among their fields of competence. The figure is divided into three colored areas: red (including scores and medians <3), orange (for scores and medians between 3 and 4) and green (for scores and medians >4). A line covers the full range from the lowest score to the highest score in the group of responding experts. The median of the scores is represented by an “x” and the interquartile range is represented by a rectangle. If the median (x) is in the red area, the aggregated quality of the criterion is low. If the median is in the orange area, the aggregated quality is average. If the median is in the green area, the aggregated quality is high. The interquartile range is an indicator of inter-expert heterogeneity. The number of criteria that fell in the orange or red areas is much higher for these two respondents than for all respondents together: 16 vs 3 in the orange area, 9 vs 2 in the red area, and only 5 vs 30 in the green area. This indicates lower levels of aggregated quality for these criteria, compared to the 8 respondents together.</p>", "links"=>[], "tags"=>["Public health", "Environmental health", "Occupational and industrial health", "Socioeconomic aspects of health", "toxicology", "Research assessment", "Research validity", "reproducibility", "Research errors", "Research reporting guidelines", "Research laboratories", "Company laboratories", "University laboratories", "Technology regulations", "Political science", "Political aspects of health", "public policy", "Sociology", "Sociology of knowledge", "endocrinologists", "qualichem", "tyl", "et"], "article_id"=>917613, "categories"=>["Medicine", "Science Policy", "Sociology"], "users"=>["Laura Maxim", "Jeroen P. Van der Sluijs"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0087738.g005", "stats"=>{"downloads"=>1, "page_views"=>7, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Quality_assessment_by_two_endocrinologists_using_Qualichem_to_evaluate_Tyl_et_al_2002_/917613", "title"=>"Quality assessment by two endocrinologists using Qualichem to evaluate Tyl et al. (2002).", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2014-01-29 03:18:00"}

{"files"=>["https://ndownloader.figshare.com/files/1365873"], "description"=>"<p>For the study of Tyl et al. (2002), of the 45 criteria, the figure represents only the 35 controversial criteria out of the total set of 45 criteria. The remaining 10 criteria were not controversial according to our definition; they received scores of 5 or 6 and were considered to be of high aggregated quality. The figure is divided in three colored areas: red (including scores and medians <3), orange (for scores and medians between 3 and 4) and green (for scores and medians >4). A line covers the full range, from the lowest score to the highest score in the group of responding experts. The median of the scores is represented by an “x” and the interquartile range is represented by a rectangle. If the median (x) is in the red area, the aggregated quality of the criterion is low. If the median is in the orange area, the aggregated quality is average. If the median is in the green area, the aggregated quality is high. The interquartile range is an indicator of inter-expert heterogeneity. Thirty of the 35 controversial criteria were of high aggregated quality (the median is in the green area). Of the five remaining criteria, three were of average aggregated quality (the median in the orange area) and two were of low aggregated quality (the median is in the red area).</p>", "links"=>[], "tags"=>["Public health", "Environmental health", "Occupational and industrial health", "Socioeconomic aspects of health", "toxicology", "Research assessment", "Research validity", "reproducibility", "Research errors", "Research reporting guidelines", "Research laboratories", "Company laboratories", "University laboratories", "Technology regulations", "Political science", "Political aspects of health", "public policy", "Sociology", "Sociology of knowledge", "tyl", "et", "qualichem"], "article_id"=>917607, "categories"=>["Medicine", "Science Policy", "Sociology"], "users"=>["Laura Maxim", "Jeroen P. Van der Sluijs"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0087738.g001", "stats"=>{"downloads"=>0, "page_views"=>9, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Quality_assessment_of_Tyl_et_al_2002_using_Qualichem_with_eight_respondents_/917607", "title"=>"Quality assessment of Tyl et al. (2002), using Qualichem with eight respondents.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2014-01-29 03:18:00"}

{"files"=>["https://ndownloader.figshare.com/files/1365874"], "description"=>"<p>For the report of Stump (2009), of the possible 45, the figure represents only the 16 controversial criteria. All the other criteria—those that are not controversial according to our definition—received scores of 5 or 6 and were considered as having a high aggregated quality. The figure is divided in three colored areas: red (including scores and medians <3), orange (for scores and medians between 3 and 4) and green (for scores or medians >4). A line covers the full range from the lowest score to the highest score in the group of responding experts. The median of the scores is represented by an “x” and the interquartile range is represented with a rectangle. If the median (x) is in the red area, the aggregated quality of the criterion is low. If the median is in the orange area, the aggregated quality is average. If the median is in the green area, the aggregated quality is high. The interquartile range is an indicator of inter-expert heterogeneity. Nine of the 16 controversial criteria were of high aggregated quality (median fell in the green area). The remaining 7 criteria were all of average aggregated quality (median fell in the orange area).</p>", "links"=>[], "tags"=>["Public health", "Environmental health", "Occupational and industrial health", "Socioeconomic aspects of health", "toxicology", "Research assessment", "Research validity", "reproducibility", "Research errors", "Research reporting guidelines", "Research laboratories", "Company laboratories", "University laboratories", "Technology regulations", "Political science", "Political aspects of health", "public policy", "Sociology", "Sociology of knowledge", "stump", "qualichem"], "article_id"=>917608, "categories"=>["Medicine", "Science Policy", "Sociology"], "users"=>["Laura Maxim", "Jeroen P. Van der Sluijs"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0087738.g002", "stats"=>{"downloads"=>0, "page_views"=>9, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Quality_assessment_of_Stump_2009_using_Qualichem_with_four_respondents_/917608", "title"=>"Quality assessment of Stump (2009), using Qualichem with four respondents.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2014-01-29 03:18:00"}

{"files"=>["https://ndownloader.figshare.com/files/1365885", "https://ndownloader.figshare.com/files/1365886", "https://ndownloader.figshare.com/files/1365887", "https://ndownloader.figshare.com/files/1365888", "https://ndownloader.figshare.com/files/1365889", "https://ndownloader.figshare.com/files/1365890", "https://ndownloader.figshare.com/files/1365891", "https://ndownloader.figshare.com/files/1365892", "https://ndownloader.figshare.com/files/1365893", "https://ndownloader.figshare.com/files/1365894"], "description"=>"<div><p>In regulatory toxicology, quality assessment of <i>in vivo</i> studies is a critical step for assessing chemical risks. It is crucial for preserving public health studies that are considered suitable for regulating chemicals are robust. Current procedures for conducting quality assessments in safety agencies are not structured, clear or consistent. This leaves room for criticism about lack of transparency, subjective influence and the potential for insufficient protection provided by resulting safety standards. We propose a tool called “Qualichem <i>in vivo</i>” that is designed to systematically and transparently assess the quality of <i>in vivo</i> studies used in chemical health risk assessment. We demonstrate its use here with 12 experts, using two controversial studies on Bisphenol A (BPA) that played an important role in BPA regulation in Europe. The results obtained with Qualichem contradict the quality assessments conducted by expert committees in safety agencies for both of these studies. Furthermore, they show that reliance on standardized guidelines to ensure scientific quality is only partially justified. Qualichem allows experts with different disciplinary backgrounds and professional experiences to express their individual and sometimes divergent views—an improvement over the current way of dealing with minority opinions. It provides a transparent framework for expressing an aggregated, multi-expert level of confidence in a study, and allows a simple graphical representation of how well the study integrates the best available scientific knowledge. Qualichem can be used to compare assessments of the same study by different health agencies, increasing transparency and trust in the work of expert committees. In addition, it may be used in systematic evaluation of <i>in vivo</i> studies submitted by industry in the dossiers that are required for compliance with the REACH Regulation. Qualichem provides a balanced, common framework for assessing the quality of studies that may or may not be following standardized guidelines.</p></div>", "links"=>[], "tags"=>["Public health", "Environmental health", "Occupational and industrial health", "Socioeconomic aspects of health", "toxicology", "Research assessment", "Research validity", "reproducibility", "Research errors", "Research reporting guidelines", "Research laboratories", "Company laboratories", "University laboratories", "Technology regulations", "Political science", "Political aspects of health", "public policy", "Sociology", "Sociology of knowledge", "qualichem", "studies", "bisphenol"], "article_id"=>917619, "categories"=>["Medicine", "Science Policy", "Sociology"], "users"=>["Laura Maxim", "Jeroen P. Van der Sluijs"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0087738.s001", "https://dx.doi.org/10.1371/journal.pone.0087738.s002", "https://dx.doi.org/10.1371/journal.pone.0087738.s003", "https://dx.doi.org/10.1371/journal.pone.0087738.s004", "https://dx.doi.org/10.1371/journal.pone.0087738.s005", "https://dx.doi.org/10.1371/journal.pone.0087738.s006", "https://dx.doi.org/10.1371/journal.pone.0087738.s007", "https://dx.doi.org/10.1371/journal.pone.0087738.s008", "https://dx.doi.org/10.1371/journal.pone.0087738.s009", "https://dx.doi.org/10.1371/journal.pone.0087738.s010"], "stats"=>{"downloads"=>47, "page_views"=>13, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/Qualichem_In_Vivo_A_Tool_for_Assessing_the_Quality_of_In_Vivo_Studies_and_Its_Application_for_Bisphenol_A/917619", "title"=>"Qualichem <i>In Vivo</i>: A Tool for Assessing the Quality of <i>In Vivo</i> Studies and Its Application for Bisphenol A", "pos_in_sequence"=>0, "defined_type"=>4, "published_date"=>"2014-01-29 03:18:00"}